Peripheral Vascular Diseases
Conditions
Keywords
peripheral arterial intervention, atherosclerosis, platelets, Age above 18
Brief summary
The Mirror Study is a randomized, double-blinded mono-centre trial the access the periinterventinal and postinterventional administration of clopidogrel in patients with peripheral vascular disease.
Detailed description
Clopidogrel is approved for secondary prevention of atherosclerosis in patients with peripheral vascular disease. Currently there are no data about the amount of platelet activation during peripheral arterial intervention, the effect of clopidogrel on platelet adhesion and its clinical impact. Patients with chronic peripheral arterial disease receive placebo or clopidogrel before the intervention and for 6 months in follow-up. Platelet activation, the effect on macro-and microcirculation will be assessed as well as clinical endpoints.
Interventions
DRUGclopidogrel
Best endovascular treatment either with one or the other drug arm should be investigated
Sponsors
University Hospital Tuebingen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Peripheral arterial disease which requires intervention
Exclusion criteria
* Patient already on coumadin or clopidogrel * Acute onset of PVD symptoms * Patient requiring an operation * Contraindication to aspirin and clopidogrel
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Platelet activation during and after the intervention | 6-12 hours | measured in a chandler loop model |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ABI | before patients leaves the hospital and at 6 months | as treatment effect |
| clinical improvement | up to 6 months | dependent on the additional drug treatment |
| Safety | up to 6 months | dependent on the drug treatment with the endovascular treatment |
| rate of occlusions | wihtin 6 months | dependent on drug treatment |
Countries
Germany
Outcome results
None listed